FDA Clears First Sensor-Pill and App System

Proteus Discover system — pill with sensor, patch, and mobile app (Proteus Digital Health)

14 November 2017. The Food and Drug Administration approved for the first time in the U.S. a system that combines pills with built-in sensors and a mobile app to track adherence. The Abilify MyCite system is a product of Otsuka Pharmaceutical, the Tokyo-based maker of the drug Abilify being delivered, and Proteus Digital Health that designed the wearable patch and app to track the drug in the body, based on its Proteus Discover system.

Abilify MyCite is made to track adherence to Abilify for people with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder — defined as manic episodes that last at least 7 days, or by manic symptoms that are so severe that the person needs immediate hospital care — and for use as an add-on treatment for depression in adults. Abilify is the brand name for aripiprazole, an oral drug approved for controlling symptoms associated with these conditions, approved by FDA in 2002.

Built into Abilify tablets is an event marker sensor made by Proteus Digital Health in Redwood City, California. The sensor, about the size of a grain of sand and made with biocompatible materials, is activated by fluids in the stomach. A MyCite patch is worn on the torso and tracks ingestion of the sensor-pill, as well as date/time and activity level, which sends signals to a MyCite mobile device app providing immediate feedback to the individual taking the drug. The app can also relay the data to web-based dashboards for tracking by clinicians and caregivers. FDA first approved the ingestible sensor in 2012.

FDA notes that Abilify MyCite should be used to track ingestion of the drug in routine cases to improve overall management of an individual’s therapy for these psychiatric conditions. The system, says the agency, should not be used for real-time tracking or in emergency situations. FDA adds that Abilify MyCite has not yet been shown to improve compliance of individuals with treatment regimens.

The Abilify MyCite system is approved for adults, but not children, and comes with a medication guide that outlines its uses and risks. FDA advises that patients continue to be monitored for suicidal thoughts and behaviors. In clinical trials, Abilify is associated with a number of adverse effects such as nausea, vomiting, constipation, headache, and dizziness. The MyCite patch, in some cases, also causes skin irritation.

Otsuka and Proteus plan to introduce the system beginning with a few health plans and providers, identifying candidates for Abilify MyCite who can benefit from its use. The system, say the companies, is designed to integrate into people’s lives and encourage a more informed dialogue between the individual and clinicians to improve medical decision-making. Participation by patients is voluntary, who can decide not to share the data or opt out completely.

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